N/A
N=172
Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT03257410 ↗Enrolled (actual)
172
Serious AEs
22.2%
Results posted
Dec 2020
Primary outcome: Primary: Reduction Ratio of Lambda Immunoglobulin FLC at Week 24 — 32.156; 17.514 percentage ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Theranova 400 dialyzer (Device); Elisio-17H dialyzer (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vantive Health LLC
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction Ratio of Lambda Immunoglobulin FLC at Week 24 |
32.156; 17.514 | — |
| PRIMARY Pre-dialysis Serum Level of Albumin at Week 24 |
4.030; 4.018 | — |
| SECONDARY Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24 |
39.3; 19.88; 33.29; 17.19 | <0.0001 sig |
| SECONDARY Reduction Ratio of Complement Factor D |
36.78; 11.71; 38.09; 14.55 | <0.0001 sig |
| SECONDARY Reduction Ratio of κ FLC |
65.63; 49.74; 59.27; 43.91 | <0.0001 sig |
| SECONDARY Reduction Ratio of Interleukin 6 |
-4.62; -22.21; -0.85; -14.83 | 0.0684 |
| SECONDARY Reduction Ratio of Tumor Necrosis Factor Alpha |
47.29; 37.9; 44.48; 34.52 | — |
| SECONDARY Reduction Ratio of β2-microglobulin |
75.67; 64.86; 73.64; 65.41 | — |
| SECONDARY Change From Baseline in Pre-dialysis β2-microglobulin at Week 24 |
-3.95; -1.16 | — |
| SECONDARY Kt/Vurea |
1.58; 1.58; 1.62; 1.51; 1.58; 1.55 | — |
| SECONDARY Change From Baseline in Pre-dialysis Serum Albumin by Visit |
-0.08; 0; -0.11; 0.00; -0.12; -0.04 | 0.0347 sig |
| SECONDARY Change From Baseline in Pre-dialysis Factor VII by Visit |
3.59; 7.79; 0.38; 9.19 | 0.1472 |
| SECONDARY Change From Baseline in Pre-dialysis Protein C by Visit |
1.12; 1.76; 0.14; -1.78 | 0.9775 |
| SECONDARY Change From Baseline in Pre-dialysis Vitamin A by Visit |
-0.29; -0.04; -0.33; -0.15 | 0.1100 |
| SECONDARY nPNA (nPCR) |
0.983; 1.056; 1.013; 1.023; 0.971; 1.030 | 0.0791 |
| SECONDARY Change From Baseline in Pre-dialysis Factor II by Visit |
3.45; 3.19; 3.85; 5.78 | 0.9001 |
| SECONDARY Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24) |
-0.20; 0.00 | 0.6576 |
| SECONDARY Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24) |
0.08; -0.23 | 0.0058 sig |
| SECONDARY Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24) |
-0.06; -0.02 | 0.034 sig |
| SECONDARY Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24) |
-0.03; -0.19 | 0.0285 sig |
| SECONDARY Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24) |
0.09; 0.43 | 0.9069 |
| SECONDARY Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24) |
1.31; 1.37 | 0.8413 |
| SECONDARY Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24) |
-0.20; 0.47 | 0.0125 sig |
| SECONDARY Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24) |
-0.04; -0.49 | 0.6891 |
| SECONDARY Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24) |
-0.01; -0.05 | 0.6043 |
| SECONDARY Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24) |
-0.82; -0.96 | 0.5067 |
| SECONDARY Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24) |
0.03; 0.01 | 0.0297 sig |
| SECONDARY Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24) |
2.74; -0.11 | 0.1325 |
| SECONDARY Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24) |
-0.12; -0.35 | 0.2304 |
| SECONDARY Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24) |
-18.54; -15.12 | 0.5785 |
| SECONDARY Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24) |
4.88; 1.93 | 0.0067 sig |
| SECONDARY Change From Baseline in Platelets at End of Study (up to Week 24) |
-8.65; 7.99 | 0.0434 sig |
| SECONDARY Change From Baseline in Erythrocytes at End of Study (up to Week 24) |
0.10; 0.04 | 0.3281 |
| SECONDARY Change From Baseline in Leukocytes at End of Study (up to Week 24) |
-0.22; 0.49 | 0.0463 sig |
| SECONDARY Change From Baseline in Basophils (%) at End of Study (up to Week 24) |
0.05; -0.02 | 0.1925 |
| SECONDARY Change From Baseline in Eosinophils (%) at End of Study (up to Week 24) |
0.17; -0.29 | 0.2569 |
| SECONDARY Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24) |
0.14; -0.69 | 0.5709 |
| SECONDARY Change From Baseline in Monocytes (%) at End of Study (up to Week 24) |
-0.49; -1.07 | 0.217 |
| SECONDARY Change From Baseline in Neutrophils (%) at End of Study (up to Week 24) |
0.16; 1.98 | 0.2386 |
| SECONDARY Change From Baseline in Pre-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24) |
-1.82; -0.69 | 0.1769 |
| SECONDARY Change From Baseline in Post-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24) |
-0.53; -0.57 | 0.8102 |
| SECONDARY Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24) |
0.33; 0.68 | 0.9672 |
| SECONDARY Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24) |
-17.45; -36.44 | 0.2697 |
| SECONDARY Kt/Vurea by Visit |
1.58; 1.58; 1.62; 1.51; 1.58; 1.55 | — |
| SECONDARY Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24) |
-0.35; -0.01 | — |
| SECONDARY Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24) |
-0.19; -0.24 | 0.7189 |
| SECONDARY Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24) |
0.04; -0.03 | 0.097 |
| SECONDARY Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24) |
-0.07; -0.18 | 0.4513 |
| SECONDARY Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24) |
-0.15; -0.02 | 0.0733 |
| SECONDARY Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24) |
-1.97; 2.19 | 0.5326 |
| SECONDARY Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24) |
-2.17; -0.51 | 0.3042 |
| SECONDARY Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24) |
-0.75; -0.01 | 0.5534 |
| SECONDARY Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24) |
1.53; 0.23 | 0.2958 |
| SECONDARY Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24) |
-1.06; -0.66 | 0.0998 |
| SECONDARY Change From Baseline in Gamma Glutamyl Transferase (U/L) at End of Study (up to Week 24) |
-0.66; -1.68 | 0.9952 |
| SECONDARY Change From Baseline in Protein (g/L) at End of Study (up to Week 24) |
-1.55; -0.95 | 0.3063 |
| SECONDARY Change From Baseline in Globulin (g/L) at End of Study (up to Week 24) |
-2.07; -1.27 | 0.1098 |
| SECONDARY Change From Baseline in High-sensitivity C-reactive Protein (mg/L) at End of Study (up to Week 24) |
-0.96; -0.40 | 0.0766 |
| SECONDARY Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24) |
3.85; 5.78 | 0.2886 |
| SECONDARY Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24) |
0.01; 0.04 | 0.4513 |
| SECONDARY Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24) |
0.14; -1.78 | 0.5992 |
| SECONDARY Change From Baseline in Tumor Necrosis Factor (pg/mL) at End of Study (up to Week 24) |
-0.47; 0.08 | 0.3836 |
| SECONDARY Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24) |
0.38; 9.19 | 0.0769 |
| SECONDARY Change From Baseline in Lambda Light Chain, Free (mg/L) at End of Study (up to Week 24) |
-19.40; 1.75 | 0.0002 sig |
| SECONDARY Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24) |
0.20; 1.64 | 0.1825 |
| SECONDARY Change From Baseline in Complement Factor D (mcg/mL) at End of Study (up to Week 24) |
0.13; 1.89 | 0.0957 |
| SECONDARY Change From Baseline in Kappa Light Chain, Free (mg/L) at End of Study (up to Week 24) |
-84.81; -43.01 | 0.0012 sig |
| SECONDARY Change From Baseline in Beta-2 Microglobulin (mg/L) at End of Study (up to Week 24) |
-3.95; -1.16 | 0.1824 |
Summary
The study evaluates the efficacy and safety of the Theranova 400 dialyzer compared with Elisio-17 H dialyzer in end stage renal disease patients receiving hemodialysis treatment. Efficacy will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Safety will be evaluated by maintaining pre-dialysis serum albumin levels and other safety events including laboratory tests and adverse events.
Patients will undergo 3 dialysis sessions per week, for 24 weeks.
Eligibility Criteria
Inclusion Criteria
- ESRD patients age 22 and older, or between ages 18 and 21 with a weight ≥ 40kg.
- Clinically stable as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing.
- Hemodialysis therapy with high-flux dialyzers for at least 3 months immediately prior to study enrollment and expected to survive for the next 12 months.
- Expected to maintain an acceptable urea clearance (Kt/V) with a dialyzer of an approximate surface area of 1.7 m2.
- Currently being dialyzed at an in-center setting, on a schedule of 3 times per week.
- Able to give informed consent after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period.
- Have a stable functioning vascular access (arteriovenous fistula, graft, or dual lumen tunneled catheter); stable access will be confirmed by observed Kt/V >= 1.2 for past 2 measurements, and/or achievement of within 15% the prescribed blood flow rate over 3 treatments prior to study entry.
Exclusion Criteria
- Are female and pregnant, lactating, or planning to become pregnant during the study period. Note: Female subjects of childbearing potential, defined as a woman 1 week.
- Are scheduled for living-donor transplantation within the study period + 3 months, plan to change to PD therapy within the next 9 months, plan to change to a home hemodialysis treatment, or plan to relocate to an area where no study center is located.
- Are currently participating in another interventional clinical study or has participated in another interventional clinical study in the past 3 months.
- Have a history of non-compliance with HD as assessed by an investigator.
- Have had a major cardiovascular or cerebrovascular event within 3 months of study entry.
- Have a history with consistent evidence of intradialytic hypotension.
- Have uncontrolled (systolic BP > 180 mmHg) hypertension.
- Have had adverse reactions to dialyzer materials.
Data sourced from ClinicalTrials.gov (NCT03257410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.